SEATTLE--(EON: Enhanced Online News)--Nativis,
Inc., a clinical stage life science bio-electronics company
developing non-invasive, safe and highly effective treatments for
cancers and other serious diseases, today announced expansion of its
clinical program in Glioblastoma Multiforme (GBM).

Chris Rivera, Nativis President and Chief Executive Officer, announced
that based on encouraging safety and survival data, the current
feasibility study in recurrent GBM, NAT-101, will be expanded to enroll
up to 32 more patients in the combination therapy arm – i.e., Nativis
Voyager® plus a standard chemotherapy drug. This study will be conducted
at 10 or more clinical sites in the US. In addition, a feasibility study
in up to 11 patients newly diagnosed with GBM, NAT-109, will begin
enrolling patients at multiple sites in the US. In this new feasibility
study, patients will be treated with Nativis Voyager® and standard of
care – i.e., temozolomide and radiotherapy – following surgical
resection. The primary endpoint in both studies is safety, and secondary
endpoints include assessment of overall survival and progression-free
survival. Previously, 58 patients were enrolled and treated in NAT-101;
21 patients received Nativis Voyager treatment alone, and 37 patients
received Nativis Voyager treatment plus standard of care. Data collected
from NAT-101 suggest that the Nativis Voyager is safe and well-tolerated
– i.e., no device-related serious adverse events were reported – and has
clinical utility in patients with recurrent GBM, based on the interim
assessment of survival data. To manage this expanded clinical program in
GBM, Nativis will engage the services of an independent clinical
research organization.

Nativis Voyager is an investigational device and is not yet approved by
the US Food and Drug Administration or any other health authority. The
protocols for NAT-101 and NAT-109 were approved by the Western
Institutional Review Board, and Nativis Voyager is considered a
non-significant risk device.

GBM, the most malignant form of astrocytoma, is the most common primary
intracranial neoplasm. The incidence of GBM increases steadily above 45
years of age with a prevalence of approximately 7,500 cases in the
United States. Despite numerous attempts to improve the outcome of
patients with GBM, the 5-year survival of these patients is only 10%,
with median survival of 14 months. Essentially all patients will
experience disease recurrence. For patients with recurrent disease,
conventional chemotherapy is generally ineffective, with response rates
less than 20%. With dismal prognoses and few effective treatments, new
therapies are critically needed for patients with brain cancer.

Earlier this year, Nativis announced it had entered into an exclusive
license agreement for the development and commercialization of Nativis’
proprietary ultra-low radio frequency energy (ulRFE®) technology
for the potential treatment of Glioblastoma Multiforme (GBM) in the
Japanese market, with Teijin Limited, a comprehensive Japanese company
expanding businesses in high-performance materials, pharmaceuticals,
home healthcare, product converting and information technology.

About Nativis, Inc.

Founded in 2002 and headquartered in Seattle, WA, Nativis is a
clinical-stage bio-electronics company. Nativis has invented and
patented a groundbreaking technology that utilizes precisely targeted,
ultra-low radio frequency energy (ulRFE®) to specifically
regulate metabolic pathways on the molecular and genetic levels –
without chemicals, radiation or drugs – delivered via a simple-to-use
non-invasive investigational device called Nativis Voyager®. The
company’s goal is to transform disease treatment on a global scale with ulRFE,
which can potentially be applied to a wide range of conditions and other
health-related needs (including agriculture, bio-fuels and veterinary
medicine, to name a few). Nativis’ initial focus is on the treatment of
patients with brain cancer (initially, glioblastoma), who are not well
served by conventional standard of care therapies, which often result in
poor outcomes and devastating side effects. Additional pre-clinical work
is being completed for melanoma, lung cancer, liver cancer, inflammatory
disease and chronic pain. Nativis Voyager® ulRFE® System for GBM is
an investigational medical device. Limited by United States law to
investigational use only.